Primary Aldosteronism Due to Adrenal HyperplasiaPhase 4GRAFT_PANCT07558811
Effects of Glucocorticoid Therapy on Renal Function in Patients With PA Complicated by CKD After Adrenalectomy: A Multicenter RCT
A Phase 4 study testing Intervention_1 in people with Primary Aldosteronism Due to Adrenal Hyperplasia, run by Ruijin Hospital.
Trial summary
This multicenter randomized controlled trial plans to enroll primary aldosteronism (PA) patients who meet the following criteria: confirmed unilateral dominant secretion by adrenal vein sampling (AVS), willingness to undergo surgery, and coexisting chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism Due to Adrenal Hyperplasia
- What is being tested?
- Intervention_1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form.
- Age 18-75 years, any gender.
- Confirmed diagnosis of primary aldosteronism (PA): positive PA screening test plus positive saline infusion test or captopril challenge test.
- Imaging findings indicating unilateral adrenal lesion, with adrenal vein sampling (AVS) confirming unilateral dominant secretion consistent with the lesion side, and planned unilateral adrenalectomy.
- Baseline eGFR 30-60 mL/min/1.73 m² OR positive proteinuria.
Who cannot join
- Use of hydrocortisone within 3 months prior to AVS.
- eGFR < 30 mL/min/1.73 m², or documented acute kidney injury (AKI) within the past 3 months.
- Overt cortisol-secreting tumor (clinical Cushing's syndrome) or requirement for long-term hormone replacement therapy.
- Severe proteinuria (24-hour urinary protein ≥ 3.5 g or ACR ≥ 300 mg/g).
- NYHA class III-IV heart failure, or acute coronary syndrome or stroke within the past 3 months.
- Severe allergy to hydrocortisone or history of serious adverse reactions to hydrocortisone.
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- Pregnancy, lactation, or planned pregnancy in the near future.
- Active malignancy or life expectancy < 1 year.
- Inability to tolerate surgery.
- Inability to comply with follow-up as judged by the investigator, or any other condition deemed unsuitable for study participation.
About this study
Official title: Effects of Glucocorticoid Therapy on Renal Function in Patients With Primary Aldosteronism Complicated by Chronic Kidney Disease After Adrenalectomy: A Multicenter Randomized Controlled Trial
This multicenter randomized controlled trial plans to enroll primary aldosteronism (PA) patients who meet the following criteria: confirmed unilateral dominant secretion by adrenal vein sampling (AVS), willingness to undergo surgery, and coexisting chronic kidney disease (CKD). Participants will be randomly assigned in a 1:1 ratio to one of two groups. To determine whether short-term postoperative hydrocortisone replacement therapy (intervention group) is superior to conventional management (surgery within 7 days after AVS, control group) in terms of reducing the decline in estimated glomerular filtration rate (eGFR) at 12 months after surgery.
- Being tested
- Intervention_1
- Keywords
- Primary Aldosteronism, chronical kidney disease, Glucocorticoid, Adrenalectomy
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention_1Drug
Postoperative administration of hydrocortisone for one month
| Study group | Role | What they receive |
|---|---|---|
| Control_1 | No intervention | this group will be not given drug |
| Intervention_1 | Active comparator | this group will be given drug Receives: Drug: Intervention_1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in eGFR from baseline at 12 months post-surgery
To compare the change in eGFR from baseline at 12 months post-surgery between the conventional group and the intervention group.
Measured: the change in eGFR from baseline at 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start22 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Aldosteronism Due to Adrenal HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianzhong, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558811
- Sponsor's protocol ID
- Ruijin2026-216
- Acronym
- GRAFT_PA
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucocorticoid Therapy on Renal Function in Patients With Primary Aldosteronism Complicated by Chronic Kidney Disease After Adrenalectomy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07558811
- Acronym / sponsor ID
- GRAFT_PA / Ruijin2026-216
- Keywords
- Primary Aldosteronism, chronical kidney disease, Glucocorticoid, Adrenalectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter randomized controlled trial plans to enroll primary aldosteronism (PA) patients who meet the following criteria: confirmed unilateral dominant secretion by adrenal vein sampling (AVS), willingness to undergo surgery, and coexisting chronic kidney disease (CKD). Participants will be randomly assigned in a 1:1 ratio to one of two groups. To determine whether short-term postoperative hydrocortisone replacement therapy (intervention group) is superior to conventional management (surgery within 7 days after AVS, control group) in terms of reducing the decline in estimated glomerular filtration rate (eGFR) at 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control_1 | No intervention | –this group will be not given drug |
| Intervention_1 | Active comparator | Drug: Intervention_1this group will be given drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent form.
- Age 18-75 years, any gender.
- Confirmed diagnosis of primary aldosteronism (PA): positive PA screening test plus positive saline infusion test or captopril challenge test.
- Imaging findings indicating unilateral adrenal lesion, with adrenal vein sampling (AVS) confirming unilateral dominant secretion consistent with the lesion side, and planned unilateral adrenalectomy.
- Baseline eGFR 30-60 mL/min/1.73 m² OR positive proteinuria.
Key exclusion criteria (10 listed)
- Use of hydrocortisone within 3 months prior to AVS.
- eGFR < 30 mL/min/1.73 m², or documented acute kidney injury (AKI) within the past 3 months.
- Overt cortisol-secreting tumor (clinical Cushing's syndrome) or requirement for long-term hormone replacement therapy.
- Severe proteinuria (24-hour urinary protein ≥ 3.5 g or ACR ≥ 300 mg/g).
- NYHA class III-IV heart failure, or acute coronary syndrome or stroke within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention_1Postoperative administration of hydrocortisone for one month | Drug | Intervention_1 |
Primary outcome
the change in eGFR from baseline at 12 months post-surgery
Time frame: the change in eGFR from baseline at 12 months post-surgery
To compare the change in eGFR from baseline at 12 months post-surgery between the conventional group and the intervention group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention_1 in people with Primary Aldosteronism Due to Adrenal Hyperplasia, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in eGFR from baseline at 12 months post-surgery (time frame: the change in eGFR from baseline at 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.